Recruiting NCT06360900
Synergistic Gut-brain Axis Modulation Via Vagal Stimulation and Support Therapy in Functional Dyspepsia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sensory device, Skills Building, Health Education, Subsensory device.
- Who it may be relevant to
- Registry conditions: Functional Dyspepsia. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
The study aims at evaluating physiological and patient-reported outcomes for a dual intervention approach including a stimulation device and support therapy in patients with functional dyspepsia.
Interventions
- Device Sensory device
Sensory vagal nerve stimulation - Behavioral Skills Building
Skills Building behavioral therapy - Behavioral Health Education
Education of FD condition - Device Subsensory device
Subsensory vagal nerve stimulation
Primary outcome measures
- Visceral Sensitivity Index (VSI) [Time frame: 8 weeks (post-treatment)]
Secondary outcome measures (2)
- Gastric peristaltic velocity [Time frame: 8 weeks (post-treatment)]
- Nepean Dyspepsia Index (NDI) [Time frame: 8 weeks (post-treatment)]
Eligibility criteria
Inclusion criteria
Age 18-65 years old (inclusive)
- Ability to give written consent and participate in behavioral intervention in English
- Willingness to attend weekly treatment sessions over live video, daily self-administered transcutaneous auricular vagus nerve stimulation (taVNS) sessions, and engage in homework during treatment
- Avoidance of alcohol, nicotine, and caffeine for 24 hours prior to study session
- Diagnosis according to the Rome IV criteria for both epigastric pain syndrome and postprandial distress syndrome subtypes
- Stable medical treatment for functional dyspepsia (FD) during 1 month before the study and during the study period
Exclusion criteria
- Previous receipt of cognitive behavioral therapy (CBT) for gastrointestinal symptoms
- Enteral or parenteral feeding
- Previous gastrointestinal surgery, electrolyte disturbances, kidney dysfunction, renal insufficiency, or iron overload disorders
- Estimated Glomerular Filtration Rate (eGFR) < 60
- Medications that affect gastrointestinal motility in addition to medications or products containing tetrahydrocannabinol (THC) will be stopped at least 7 days prior to the start of the study and for the duration of the study. However, anti-depressants (SSRI's, TCA's) may be allowed in order to reduce the risk of worsening neuropsychiatric disease, though it will be up to the study team and the Principal Investigator whether subjects on anti-depressants will be able to participate in the study
- Intellectual disability by history
- Diabetes, mitochondrial disease, severe autonomic dysfunction, and small fiber polyneuropathy
- No active clinical acupuncture therapy
- Illicit drugs or opioid usage
- History of arrhythmias
- Current pregnancy/breastfeeding
- Contraindications for magnetic resonance imaging (MRI) (implanted ferromagnetic objects, claustrophobia)
- Weight > 450 lbs. (limit of the MRI table)
- Allergy to pineapple (used in the test meal during MRI)
- Any other condition interfering with study requirements, according to the Investigator
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Factorial
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Massachusetts General Hospital — Boston
Identifiers
NCT: NCT06360900 · 2024P000849 · R01DK136243